Regorafenib

IMPORTANT WARNING:

Regorafenib is used to treat colon and rectal cancer (cancer that begins in the large intestine or the rectum) that has spread to other parts of the body in people who have not been treated successfully with certain other medications. Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Regorafenib comes as a tablet to take by mouth. It is usually taken with a low-fat breakfast once a day for 3 weeks and then skipped for 1 week. This treatment period is called a cycle, and the cycle may be repeated for as long as your doctor recommends. Take regorafenib at the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take regorafenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Take regorafenib with a low-fat breakfast that contains less than 30% of calories from fat (each gram of fat contains 9 calories). Examples of a low-fat breakfast include 2 slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly, and 8 ounces of skim milk (about 320 calories and 8 grams of fat); or 1 cup of cereal, 8 ounces of skim milk, 1 slice of toast with jam, apple juice, and 1 cup of coffee or tea (about 520 calories and 2 grams of fat). Talk to your doctor about other low-fat breakfasts to eat with regorafenib.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may decrease your dose of regorafenib or tell you to stop taking regorafenib for a period of time during your treatment. This will depend on how well the medication works for you and any side effects you may experience. Continue to take regorafenib even if you feel well. Do not stop taking regorafenib without talking to your doctor.

Regorafenib is not available at retail pharmacies. Your medication will be mailed to you or to your doctor from a specialty pharmacy. Ask your doctor if you have any questions about how you will receive your medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking regorafenib,

• tell your doctor and pharmacist if you are allergic to regorafenib, any other medications, or any of the ingredients in regorafenib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements, you are taking or plan to take. Be sure to mention any of the following: anticoagulants (''blood thinners'') such as warfarin (Coumadin); certain antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); clarithromycin (Biaxin, in Prevpac); irinotecan (Camptosar); rifampin (Rifadin, Rifamate, in Rifater); or telithromycin (Ketek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort. You should not take St. John's wort while taking regorafenib.
• tell your doctor if you have a wound that has not healed or if you have or have ever had bleeding problems, high blood pressure, or heart, kidney or liver disease. Also tell your doctor if you recently had surgery.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking regorafenib and for up to 2 months after stopping treatment. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while taking regorafenib or within 2 months after stopping the medication, call your doctor. Regorafenib may harm the fetus.
• tell your doctor if you are breast-feeding.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking regorafenib. Your doctor probably will tell you to stop taking regorafenib at least 2 weeks before your surgery. Your doctor will tell you when it is safe for you to start taking regorafenib again after your surgery.
• you should know that your blood pressure may increase during your treatment with regorafenib. Your doctor will check your blood pressure during your treatment.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss a dose of regorafenib, take the missed dose as soon as you remember it on that day. Do not take two doses on the same day to make up for a missed one.

Regorafenib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness

• weakness

• loss of appetite

• diarrhea

• swelling, pain, and redness of the lining of your mouth or throat

• weight loss

• hoarseness or other change in the sound of your voice

• fever, sore throat, chills, and other signs of infection

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• chest pain

• shortness of breath

• dizziness or feeling faint

• severe pain in the abdomen

• swelling of the abdomen

• high fever

• chills

• severe diarrhea

• severe headache

• seizure

• confusion

• changes in vision

• dry mouth, muscle cramps, or decreased urination

• redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet

• rash

• vomiting blood or vomiting material that looks like coffee grounds

• pink or brown urine

• red or black (tarry) stools

• coughing up blood or blood clots

• abnormally heavy menstrual bleeding (periods)

• unusual vaginal bleeding

• frequent nosebleeds

Regorafenib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not place the tablets in other containers, such as daily or weekly pill boxes, and do not remove the desiccant (drying agent) from the container. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any unused tablets 28 days after the bottle is first opened. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• rash or other skin changes

• voice changes or hoarseness

• diarrhea

• swelling inside the nose or mouth

• dry mouth

• decreased appetite

• tiredness

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Last Revised - 02/15/2013